Amalgam regulations am I compliant?

Amalgam regulations am I compliant?

In March 2017, the European Parliament approved the final version of its Regulation on Mercury with a view to endorsing the Minamata Treaty of 2013. This global environmental treaty aims to reduce the release of mercury into the environment and as a result, both the EU’s Mercury Regulation and the Minamata Treaty recommend a phase-down of the use of dental amalgam.

The Regulation does not ban the use of amalgam completely yet. But, there is still an intention to phase it out on environmental grounds, possibly by 2030, but only following a full feasibility study (which will involve contributions from various interested parties such as the Council of European Dentists).

Which parts of the Regulation are relevant to me?

These are the main points to be aware of in relation to dentistry:

  • Dental amalgam can only to be used in pre-dosed encapsulated form; the use of bulk mercury by practitioners will be prohibited from 1 January 2019
  • Amalgam separators will become mandatory from 1 January 2019 and for separators installed from January 2018, they must retain at least 95 per cent of amalgam particles. By 1 January 2021 all separators must retain at least 95 per cent of amalgam particles.
  • From 1 January 2018, practitioners must ensure that their amalgam waste (including amalgam residues, particles and fillings, and teeth or parts of teeth contaminated with dental amalgam), is handled and collected by an authorised waste management establishment.
  • From 1 July 2018, amalgam should not be used in the treatment of:
    Deciduous teeth except when strictly deemed necessary by the practitioner on the ground of specific medical needs of the patient
    Children under 15 years
    Pregnant or breastfeeding women

What does this mean for me and my patients?

  • Can I still use amalgam? Amalgam can still be used on certain patients with the exception of those mentioned above and unless there are any other relevant contraindications. Amalgam is proven to be durable, strong, load bearing, easy to manipulate and to use in cavities of all sizes, bacteriostatic and cost-effective. Remember to advise your patients of the evidence surrounding amalgam’s properties and the fact that dental amalgam has been in use and studied extensively for 150 years – it still remains appropriate for a range of clinical situations!
  • Should patients have their existing amalgams removed? There is no justification for removing clinically sound amalgam fillings, except for those who have been diagnosed with a specific allergy to the components that make up the filling material. However, this is usually rare. It should be noted that the actual process of removing amalgams temporarily releases mercury vapour.
  • What evidence exists surrounding the restrictions on the specified patient groups within the Regulation? There is no reliable evidence for restricting the specific use of amalgam in children under 15 and pregnant or breastfeeding women based on adverse health effects of amalgam. However, the restrictions could be linked to the phasing down approach of amalgam as well as the fact that deciduous teeth are smaller and usually have smaller cavities which could benefit from minimally invasive composite restorations.
  • What will happen with Britain leaves the EU? It is unclear how Brexit will affect transfer of the EU Regulation into UK law or its retention in UK law. However, the ban on importing mercury into Europe may lead to reduced availability of amalgam which is likely to increase the cost of it.

Dental Directory is here to assist you in ensuring your compliance.

  • DBG members can benefit from reduced rates on clinical waste through Cannon Hygiene, with amalgam waste service starting at just £0.40 per week.
  • Dental Directory customers also receive discount at Mi-Tec for repairs and servicing on their capsule mixers.